A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

NCT07535034 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FYU-981-CRYS-201
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.

Conditions

Gout

Keywords

Dotinurad; Xanthine Oxidase Inhibitors

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24

  Week 24

Secondary Outcomes (7)

• Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24

  Weeks 16, 20 and 24

• Percentage of Participants With an sUA Level <6.0 <5.0, <4.0, and <3.0 mg/dL at Each Visit

  Up to Week 40

• Mean Change From Baseline in sUA at Week 24

  Baseline and Week 24

• Absolute Change from Baseline in sUA Levels at Each Visit

  Baseline to Week 40

• Percent Change from Baseline in sUA Levels at Each Visit

  Baseline to Week 40

Study Arms (2)

Dotinurad

EXPERIMENTAL

The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take dotinurad (Treatment Period 1) followed by a 12-week period where participants will continue to take dotinurad (Treatment Period 2).

Drug: Dotinurad

Placebo + Placebo to Dotinuard

EXPERIMENTAL

The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).

Drug: Dotinurad; Other: Placebo

Interventions

Dotinurad DRUG

Over-encapsulated tablets containing active drug substance administered orally.

Dotinurad; Placebo + Placebo to Dotinuard

Placebo OTHER

Capsules containing microcrystalline cellulose administered orally.

Placebo + Placebo to Dotinuard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
• Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:
• History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.
• Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).
• sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).
• Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
• Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of trial drug.

You may not qualify if:

• History of or presence of kidney stones within 1 year prior to Screening.
• History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
• Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
• Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.
• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.

Sponsors & Collaborators

• Crystalys Therapeutics: lead

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Gout

Interventions

dotinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Clinical Trial Lead

CONTACT

(858) 356-4740; ClinicalTrials@crystalystx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP